231 reports included information about the type of implant. Of those, 203 were textured implants and 28 involved smooth implants. 126 reported the use of saline-filled implants.

The FDA said that case histories suggest that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants.

The agency said that most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation.

The FDA offers the following recommendations regarding implants and BIA-ALCL.

Health Care Providers:

If you have patients with breast implants, you should continue to provide them routine care and support. BIA-ALCL is a very rare condition; when it occurs, it has been identified most frequently in patients undergoing implant revision operations for late onset, persistent seroma. Because it has generally only been identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, prophylactic breast implant removal in patients without symptoms or other abnormality is not recommended.

Current recommendations include the steps below.

Be aware that most confirmed cases of BIA-ALCL have occurred in women with textured breast implants. Provide the manufacturers’ labeling as well as any other educational materials to your patients before surgery and discuss with them the benefits and risks of the different types of implants.

Consider the possibility of BIA-ALCL when you have a patient with late onset, persistent peri-implant seroma. In some cases, patients presented with capsular contracture or masses adjacent to the breast implant. If you have a patient with suspected BIA-ALCL, refer her to an appropriate specialist for evaluation. When testing for BIA-ALCL, collect fresh seroma fluid and representative portions of the capsule and send for pathology tests to rule out BIA-ALCL. Diagnostic evaluation should include cytological evaluation of seroma fluid with Wright Giemsa stained smears and cell block immunohistochemistry testing for cluster of differentiation (CD) and Anaplastic Lymphoma Kinase (ALK) markers.

Develop an individualized treatment plan in coordination with the patient’s multi-disciplinary care team. Consider current clinical practice guidelines, such as those from the Plastic Surgery Foundation or the National Comprehensive Cancer Network (NCCN) when choosing your treatment approach.

Report all confirmed cases of ALCL in women with breast implants to the FDA. In some cases, the FDA may contact you for additional information. The FDA will keep the identities of the reporter and the patient confidential.

Submit case reports of BIA-ALCL to the PROFILE Registry to contribute to a better understanding of the causes and treatments of BIA-ALCL.

Patients

Educate yourself about breast implants before agreeing to surgery. Breast implants approved in the U.S. can be filled with either saline or with silicone gel. They come in different sizes and shapes and have either smooth or textured surfaces (shells). Additional information is available on FDA’s Breast Implants website.

Although it is rare, BIA-ALCL appears to develop more frequently in women with textured implants than in women with smooth-surfaced implants. Before getting breast implants, make sure to talk to your health care provider about the benefits and risks of textured-surface vs. smooth-surfaced implants.

If you have breast implants, there is no need to change your routine medical care and follow-up. BIA-ALCL is rare. Although not specific to BIA-ALCL, you should follow standard medical recommendations including:

Follow your doctor’s instructions on how to monitor your breast implants. If you notice any changes, contact your health care provider promptly to schedule an appointment. Get routine mammography screening and ask for a technologist specifically trained in performing mammograms on patients with breast implants.

If you have silicone gel-filled breast implants, get periodic magnetic resonance imaging (MRI) to detect ruptures as recommended by your health care provider. The FDA-approved product labeling for silicone gel-filled breast implants states that the first MRI should occur three years after implant surgery and every two years thereafter.

To improve our understanding of this rare finding, please continue to report all confirmed cases of ALCL in women with breast implants, with as much detail as possible, through FDA’s MedWatch Program.

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